Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

Barrett's Esophagus Clinical Trial

Official title:

Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01477177
• Other study ID #: 11-004237
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.

Description:

Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 98 Years

Eligibility

Inclusion Criteria:

• Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.

• Previous fundoplication surgery is permitted

• Age 18 years to 98 years

• Ability to provide written, informed consent

Exclusion Criteria:

• Inability to obtain biopsies due to anticoagulation, varices, etc.

• Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.

• Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.

• Worse than Grade B erosive esophagitis

• Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• Polar Wand carbon dioxide cryotherapy
Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Chek-Med Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification	The reduction of Barrett's segment length and histology classification will be measured at 12 months.	12 months
Secondary	Reduction in Barrett's Segment Length, Using the Prague Classification		6 and 12 months
Secondary	Assessment of Complications	Specific complications are GI Bleeding and Perforation and Stricture and Ulceration	12 months
Secondary	Assessment of Post-ablation Symptoms	Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat	12 months
Secondary	Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification	The reduction of Barrett's segment length and histology classification will be measured at 6 months.	6 months